Patient interface device

ABSTRACT

A patient interface device that includes a support member sized and configured to span at least a portion of a patient&#39;s face while remaining below the patient&#39;s eyes responsive to the patient interface device being donned by such a patient and a sealing assembly operatively coupled to the support member such that the support member is moveable relative to the support member. The support member defines a gas carrying conduit adapted to carry a flow of gas to the sealing assembly. The support member is a single-piece unitary member and includes a conduit coupling portion adapted to be coupled to a patient circuit.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of and claims priority under 35U.S.C. §120 from U.S. patent application Ser. No. 12/118,905, filed May12, 2008, now U.S. Pat. No. 7,900,628, which is a Continuation of andclaims priority under 35 U.S.C. §120 from U.S. patent application Ser.No. 11/374,942, filed Mar. 14, 2006, now U.S. Pat. No. 7,370,652, whichis a Continuation-In-Part (CIP) and claims priority under 35 U.S.C. §120from U.S. patent application Ser. No. 11/074,410, filed Mar. 8, 2005,now U.S. Pat. No. 7,856,982, which claims priority under 35 U.S.C.§119(e) from provisional U.S. patent application No. 60/552,136, filedMar. 11, 2004, the contents of which each of which are incorporatedherein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention pertains to a patient interface device thatprovides a stable platform supporting a sealing assembly for coupling aflow of gas with an airway of a patient, is relatively small to minimizethe amount of material supported on the patient's face and head, and yetprovides a high degree of adjustability, so that the patient interfacedevice fits comfortably on a wide variety of differently sized andshaped patients.

2. Description of the Related Art

There are numerous situations where it is necessary or desirable todeliver a flow of breathing gas non-invasively to the airway of apatient, i.e., without intubating the patient or surgically inserting atracheal tube in the esophagus. For example, it is known to ventilate apatient using a technique known as non-invasive ventilation. It is alsoknown to deliver continuous positive airway pressure (CPAP) or variableairway pressure, such as a bi-level pressure that varies with thepatient's respiratory cycle or an auto-titrating pressure that varieswith the monitored condition of the patient. Typical pressure supporttherapies are provided to treat a medical disorder, such as sleep apneasyndrome, in particular, obstructive sleep apnea (OSA), or congestiveheart failure.

Non-invasive ventilation and pressure support therapies involve theplacement of a patient interface device, which is typically a nasal ornasal/oral mask, on the face of a patient to interface the ventilator orpressure support system with the airway of the patient so that a flow ofbreathing gas can be delivered from the pressure/flow generating deviceto the airway of the patient. It is known to maintain such masks on theface of a patient by a headgear having upper and lower straps, eachhaving opposite ends threaded through connecting elements provided onthe opposite sides and top of a mask.

Because such masks are typically worn for an extended period of time, avariety of concerns must be taken into consideration. For example, inproviding CPAP to treat OSA, the patient normally wears the patientinterface device all night long while he or she sleeps. One concern insuch a situation is that the patient interface device is as comfortableas possible, otherwise the patient may avoid wearing the interfacedevice, defeating the purpose of the prescribed pressure supporttherapy. It is also important that the interface device provides a tightenough seal against a patient's face without discomfort. A problemarises in that in order for the mask to maintain a seal without anyundue gas leaks around the periphery of the mask, the mask cushion maybe compressed against the patient's face. This is most notable, forexample, in masks having a bubble type cushion. While the bubble cushionitself is comfortable, it does not provide adequate support, which maycause gas leaks around the periphery of the mask. The bubble effect isdiminished when the headgear strap force is increased to improvestability.

Some conventional respiratory masks attempt to enhance mask stability byproviding a relatively large structure that must be mounted on thepatient's face. Therefore, an advantage exists for a respiratory maskthat minimizes the amount of material that must be supported on thepatient's head and face, yet provides a relatively high degree ofstability, so that that the mask is not easily dislodged from thepatient. Another advantage exists for a respiratory mask that evenlydistributes the headgear strapping force needed to hold the mask on thepatient at locations on the patient's face that are best suited tohandle such forces.

A further advantage exists for a respiratory mask that avoids providingany structural features near the patient's eyes. This advantage isparticularly important for patient's who desire to where glasses whilewearing the mask and for patient's that tend to feel claustrophobic whena structure is provided at or near their eyes. Avoiding the ocular areaalso eliminates or avoids the leakage of gas into the user's eyes, whichcan cause great discomfort. A still further advantage exists for a maskthat accomplishes these functions while also providing a relatively highdegree of adjustability, so that a common mask style or configurationcan be fitted to a variety of differently sized and shaped patients.

SUMMARY OF THE INVENTION

Accordingly, it is an object of the present invention to provide apatient interface device that overcomes the shortcomings of conventionalinterface devices. This object is achieved according to one embodimentof the present invention by providing a patient interface device thatincludes a support member sized and configured to span at least aportion of a patient's face while remaining below the patient's eyesresponsive to the patient interface device being donned by such apatient and a sealing assembly operatively coupled to the support membersuch that the support member is moveable relative to the support member.The support member defines a gas carrying conduit adapted to carry aflow of gas to the sealing assembly. The support member is asingle-piece unitary member and includes a conduit coupling portionadapted to be coupled to a patient circuit.

These configurations for the patient interface device of the presentinvention provide a stable platform that supports the sealing assemblyon the patient, while minimizing the amount of material worn on thepatient's face and head. It also provides a high degree ofadjustability, so that the patient interface device fits comfortably ona wide variety of differently sized and shaped patients.

These and other objects, features, and characteristics of the presentinvention, as well as the methods of operation and functions of therelated elements of structure and the combination of parts and economiesof manufacture, will become more apparent upon consideration of thefollowing description and the appended claims with reference to theaccompanying drawings, all of which form a part of this specification,wherein like reference numerals designate corresponding parts in thevarious figures. It is to be expressly understood, however, that thedrawings are for the purpose of illustration and description only andare not intended as a definition of the limits of the invention. As usedin the specification and in the claims, the singular form of “a”, “an”,and “the” include plural referents unless the context clearly dictatesotherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a first embodiment of a patientinterface device according to the principles of the present inventionshown schematically connected to a pressure support system;

FIG. 2 is a perspective view of the patient interface device of FIG. 1shown being worn by a patient;

FIG. 3 is an exploded view of the patient interface device of FIG. 1;

FIG. 4 is an exploded view showing the connection of the sealingassembly to the support member in the patient interface device of FIG.1;

FIG. 5 is a perspective view of a second embodiment of a patientinterface device according to the principles of the present invention;

FIG. 6 is a detailed view of the support member and the frame in thepatient interface device of FIG. 5;

FIG. 7 is a perspective view of the patient interface device of FIG. 5shown being worn by a patient;

FIG. 8 is an exploded view of the patient interface device of FIG. 5;

FIG. 9 is an exploded view showing the connection of the sealingassembly to the support member in the patient interface device of FIG.5;

FIG. 10 is a perspective view, partially in section, showing theinteraction between the support member and the frame in the patientinterface device of FIG. 5;

FIG. 11 is a sectional view of a further embodiment for a sealingassembly suitable for use with the patient interface device of thepresent invention;

FIG. 12 is a sectional view of a still further embodiment for a sealingassembly suitable for use with the patient interface device of thepresent invention;

FIG. 13 is a partially exploded view of a first embodiment of a headgearattachment assembly (shown unassembled) suitable for use with thepatient interface device of the present invention;

FIG. 14 is a sectional view of the headgear attachment assembly of FIG.13;

FIG. 15 is a partially exploded view of a second embodiment of aheadgear attachment assembly (shown unassembled) suitable for use withthe patient interface device of the present invention;

FIG. 16 is a sectional view of the headgear attachment assembly of FIG.15;

FIG. 17 is a perspective view of a third embodiment of a headgearattachment assembly (shown unassembled) suitable for use with thepatient interface device of the present invention;

FIG. 18 is a sectional view of the headgear attachment assembly of FIG.17;

FIG. 19 is a perspective view of a fourth embodiment of a headgearattachment assembly (shown unassembled) suitable for use with thepatient interface device of the present invention;

FIGS. 20 and 21 are side views showing the coupling operation of theheadgear assembly of FIG. 19;

FIG. 22 is a front perspective view of a fifth embodiment of a headgearattachment assembly (shown unassembled) suitable for use with thepatient interface device of the present invention;

FIG. 23 is a perspective view of the headgear attachment assembly ofFIG. 22 with the cover portion removed;

FIG. 24 is a perspective view of the headgear attachment assembly ofFIG. 22 shown assembled;

FIGS. 25A and 25B are perspective and side views, respectively, of athird embodiment of a patient interface device according to theprinciples of the present invention;

FIGS. 26A and 26B are perspective and side views, respectively, of afourth embodiment of a patient interface device according to theprinciples of the present invention;

FIGS. 27A-27C are front and perspective views of a fifth embodiment of apatient interface device according to the principles of the presentinvention shown on a patient;

FIG. 28 is a bottom view of the patient interface device of FIGS.27A-27C;

FIG. 29 is an exploded view of the patient interface device of FIGS.27A-27C;

FIG. 30 is a detailed view of the nasal prongs and support member in thepatient interface device of FIGS. 27A-27C;

FIGS. 31A-31C are a perspective, front, and side views, respectively, ofa sixth embodiment of a patient interface device according to theprinciples of the present invention shown on a patient;

FIGS. 32A and 32B are perspective views of a seventh embodiment of apatient interface device according to the principles of the presentinvention shown on a patient;

FIGS. 33A and 33B are perspective views of an eighth embodiment of apatient interface device according to the principles of the presentinvention shown on a patient;

FIGS. 34A and 34B are perspective and side views, respectively, of aninth embodiment of a patient interface device according to theprinciples of the present invention shown on a patient;

FIGS. 35A and 35B are perspective and front views, respectively, of atenth embodiment of a patient interface device according to theprinciples of the present invention shown on a patient;

FIGS. 36A-36C are perspective, front, and side views, respectively, ofan eleventh embodiment of a patient interface device according to theprinciples of the present invention shown on a patient;

FIG. 37 is a perspective view of a twelfth embodiment of a patientinterface device according to the principles of the present inventionshown on a patient;

FIG. 38 is a side and detailed view of a portion of the patientinterface device of FIG. 37;

FIG. 39 is a front view of a thirteenth embodiment of a patientinterface device according to the principles of the present inventionshown on a patient;

FIG. 40 is a perspective view of a further embodiment for a sealingassembly suitable for use with the patient interface device of thepresent invention;

FIG. 41 is a perspective view of a fourteenth embodiment of a patientinterface device according to the principles of the present inventionshown on a patient;

FIG. 42 is a side view of a portion of the patient interface device ofFIG. 41 showing the movement of the nasal prongs on the support member;

FIG. 43 is a side view of a fifteenth embodiment of a patient interfacedevice according to the principles of the present invention shown on apatient;

FIG. 44 is a side view of a sixteenth embodiment of a patient interfacedevice according to the principles of the present invention shown on apatient;

FIG. 45 is a rear view of the patient interface device of FIGS. 44; and

FIG. 46 is a perspective view showing an alternative configuration forattaching a sealing assembly to a support member;

FIG. 47 is a perspective view of a support frame used in the sealingassembly of FIG. 46;

FIG. 48 is a perspective view illustrating the attachment of the supportframe to the support member in the embodiment of FIGS. 46; and

FIG. 49 is a cross sectional view of the attachment of the sealingassembly to the support member in the embodiment of FIG. 46.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

FIGS. 1-4 illustrate a first embodiment of a patient interface device 30according to the principles of the present invention. Patient interfacedevice 30 is shown schematically connected to a pressure support system32 via a patient circuit 34, which communicates gas from the pressuresupport system to the patient interface device. Pressure support system32 is any conventional ventilation or pressure support system.

Examples of such pressure support systems include, but are not limitedto: a ventilator, continuous positive airway pressure (CPAP) device, ora variable pressure device, e.g. an auto-titrating device, proportionalassist ventilation (PAV®) device, proportional positive airway pressure(PPAP®) device, C-Flex™ device, Bi-Flex™ device, or a BiPAP® devicemanufactured and distributed by Respironics, Inc. of Pittsburgh, Pa., inwhich the pressure provided to the patient varies with the patient'srespiratory cycle so that a higher pressure is delivered duringinspiration than during expiration, or other pressure support device.

Patient interface device 30 includes a frame 36 sized and configured tospan at least a portion of a patient's face while remaining below thepatient's eyes when the patient interface device is donned by thepatient. FIG. 2 shows patient interface device 30 being worn by apatient. A support member 38 is adjustably coupled to frame 36. In anexemplary embodiment, support member 38 is tubular shaped and insertsthrough a pair of slots provided in the frame and rotates relative tothe frame, as indicated by arrow A in FIG. 1. The frame and supportmember are preferably formed from a rigid, lightweight material, such asplastic. However, frame 36 is preferably slightly bendable to allow itto flex when the patient interface device is donned by the patient.

A sealing assembly 40 is attached to support member 38. In theembodiment shown in FIGS. 1-4, sealing assembly 40 is a cushion type ofseal that includes a sealing surface 42 adapted to engage a surface of apatient and to surround a patient's nares. An opening 44 is provided inseal 40 to communicate an interior of the seal with an airway of thepatient. It can thus be appreciated that sealing assembly 40, in thisembodiment, functions much like a conventional nasal seal. Sealingassembly 40 is preferably formed from a unitary piece of material, suchas silicone, rubber, foam, or gel. It is to be understood, however, thatother materials, in addition to or in place of these materials, can beused in the sealing assembly. The present invention also contemplatesthat the sealing assembly can be formed from a combination of materials,such as rigid, semi-rigid, and non-rigid materials to provide supportfor the cushion where desired. The sealing assembly can also includefeatures associated with conventional sealing seals or cushions, such asproviding one or more flaps at a distal end portion of the seal,providing an adhesive on at least a portion of the patient contactingsurface of the seal, or any combination thereof

As best shown in FIGS. 3 and 4, sealing assembly 40 attaches to supportmember 38 by mounting the sealing assembly on a support flange 46provided on the support member. Support flange 46 includes an opening tocommunicate gas from an interior of the support member to the interiorof the seal. A channel 48 is also provided on the support membercontacting surface of sealing assembly 40 so that the sealing assemblyslips at least partially around the circumference of the support member.To further assist in attaching and aligning the sealing assembly on thesupport member, a pair of tabs 50 are provided on the support member.Tabs 50 insert into respective detents 52 provided in sealing assembly40. An alternative configuration for attaching the sealing assembly tothe support member in a snap-on configuration is illustrated in FIGS.46-49 and discussed below.

Because the patient interface device of the present invention isintended for use in a non-invasive ventilation-type ofventilation/pressure support system, an exhaust assembly 41 must beprovided along the gas flow path to allow the patient's exhaled gassesto vent to atmosphere. In the present embodiment, exhaust assembly 41 isprovided proximate to sealing assembly 40. Placing the exhaust assembly41 close the sealing assembly minimizes the deadspace in the breathingcircuit.

The present invention contemplates that exhaust assembly 41 can have anyconfiguration, so long as the function of exhausting a sufficient amountof gas to atmosphere is achieved. For example, the exhaust assembly canbe configured to provide a continuous flow rate for the venting ofexhaust gas to atmosphere, or can be configured to provide a variableflow rate; dependent, for example, on the pressure of the gas in theclosed system. In the illustrated embodiment, exhaust assembly 41 isdefined by a plurality of vent holes 43 provided in the wall of supportmember 38. The number, size, hole pattern, and shape of the holes canhave any configuration. One example of a multiple-hole type of exhaustassembly suitable for use in the present invention is disclosed in U.S.patent application Ser. No. 10/119,673 filed Apr. 10, 2002 (“the '673application”) and U.S. Publication No. 2003/0005931 published, Jan. 9,2003. It is to be understood that other types of exhaust assemblies,including those described in the '673 application can be used. It shouldalso be noted that only one exhaust assembly need be provided on thepatient interface device, so long as the exhaust flow rate is sufficientto provide an adequate exhaust gas venting function.

A pair of patient contacting members 54 are coupled to frame 36 tosupport the frame on a patient's face. The patient contacting membersare attached to end portions of the frame such that the patientcontacting members overlie the user's zygomatic bones, i.e., cheekbones.This location on the face is believed to be a location that isparticularly well suited to support the strapping force imposed on theface when the patient interface device is attached on the head. Therelatively large size of the patient contacting member, and, inparticular, the pad portion of the patient contacting member, helpdisperse the strapping force of the mask over a wide area on the face.

Patient contacting members 54 include a pad 56 and a pad support 58. Pad56 can either be permanently or detachably attached to the pad support.If detachable, differently sized or configured pads can be used with thepatient interface device to allow a wide variety of customization. Itcan be appreciated that pad 56 can be attached to pad support 58 in anyconventional manner. Pad support 58 is preferably formed from a rigid,lightweight material, such as plastic. Pad support 58 and/or pad 56 alsopreferably includes a contoured patient contacting surface 60 that isgenerally concave so that the patient contacting member has a shape thatcomfortably conforms to the human cheekbone.

Pad 56 is preferably formed from a unitary piece of material, such assilicone, rubber, foam, or gel. However, other materials, in addition toor in place of these materials, can be used. The present invention alsocontemplates that the pad can be formed from a combination of materials,such as rigid, semi-rigid, and non-rigid materials to provide supportwhere desired. The present invention further contemplates that aremovable covering, such as a cloth or fabric slip-cover, can beprovided over the pads. Such a covering helps maintain the cleanlinessof the pads and increases patient comfort, for example, by allowingmoisture under the pad to be absorbed in the covering.

In a preferred embodiment of the present invention, patient contactingmembers 54 are rotateably attached to frame 36 such that the patientcontacting members can rotate relative to the frame, as generallyindicated by arrow B in FIG. 1. The rotateable attachment of the patientcontacting members to the frame can be accomplished in any conventionalmanner. The illustrated embodiment, for example, shows a protrusion 62provided on frame 36 to which the patient contacting members attach. Areceptacle 64 is provided in the patient contacting members for engagingand attaching to the protrusion. The movement of the patient contactingmembers relative to the frame can take place in discrete steps or in acontinuous fashion depending on the technique used to rotateably couplethe patient contacting members to the frame.

Patient interface device 30 is held on the patient's head by means of aheadgear assembly 66. Headgear assembly 66 includes at least oneheadgear strap 68 that attaches to a headgear attachment portion 70 ofpatient contacting member 54. Headgear strap 68 is formed from anymaterial sufficiently lightweight and strong to provide the strappingforced need to keep the patient interface device on the user, and ispreferably air or gas permeable. A LYCRA® laminated foam and NEOPRENE®are examples of suitable materials for the headgear straps.

In the illustrated embodiment, headgear clips 72 are provided at theends of the headgear strap to selectively attach the headgear straps tothe patient interface device. It is to be understood that a singleheadgear clip can be provide at one end of the headgear strap, becausedetaching one end of the headgear strap from the patient interfacedevice should be sufficient to allow the patient interface device to beremoved from the patient. The combination of (1) the portion of theheadgear attachment portion of patient contacting member and (2) theheadgear clips, which cooperate to selectively attach the headgearstraps to the patient interface device, are collectively referred toherein as the “headgear attachment assembly.”

The length of the headgear strap can be fixed or adjustable. Ifadjustable, the length can be adjusted using any conventional technique.For example, the present invention contemplates looping a free end ofthe headgear strap through a slot 74 provided in headgear clip 72. Thefree end is then attached at any desired location along the length ofthe headgear strap using any conventional attachment technique, such asa hook and loop fastener, i.e., VELCRO®, or a snap. The free end of thestrap that is pulled through the headgear clip to control the overalllength of the headgear strap. It is preferable that once the overalllength of the headgear strap is adjusted to suit the patient's head, itremains fixed. To make this possible, detachable headgear clip(s) 72 areused to attach the headgear to the headgear attachment portion of thepatient contacting member. This avoids the need for the patient toreadjust the headgear straps each time the patient interface device isremoved.

In the embodiment illustrated in FIGS. 1-3, headgear clip 72 is agenerally planar piece of material with a deflectable member 76protruding slightly therefrom. Headgear attachment portion 70 of patientcontacting member 54 includes a receptacle 78 that receives at least aportion of the deflectable member when the headgear clip is fullyinserted into a receiving cavity 80 formed in the headgear attachmentportion. When the headgear clip is fully inserted into a receivingcavity, the deflectable member 76 moves to its biased position andengages an edge of receptacle 78 such that the headgear clip cannot bepulled out of receiving cavity 80. FIGS. 1 and 2 show the headgear clipinserted into the cavity, and FIG. 3 shows the headgear clip detachedfrom the headgear attachment portion.

In this embodiment, receptacle 78 is a circular opening defined inheadgear attachment portion 70 so that deflectable member 76 is exposedwhen the headgear clip is fully inserted into a receiving cavity. Todetach the headgear clip from patient contacting member 54, a force isapplied on the exposed portion of the deflectable member causing theedge of the deflectable member to disengage from an edge of receptacle78, thereby allowing the headgear clip to be slid out of receivingcavity 80. The circular shape of the opening forming receptacle 78 andthe complimentary circular shape of deflectable member 76, as well asthe relative sizing of these two members, are selected so as to enablethe headgear clip to rotate relative to the headgear attachment portion70, as indicated by arrow C in FIG. 1. Of course, the present inventioncontemplates that other shapes and configurations for receptacle 78 anddeflectable member 76 can be used, including shapes that would preventsuch rotational movement of the headgear clip relative to the frame.

As noted above, the flow of gas generated by pressure support system 32is communicated to patient interface device 30 via patient circuit 34.In the exemplary embodiment, the patient circuit connects to a Y-piece82, and a pair of hollow leg conduits 84 connect the diverging portionsof the Y-piece to elbow couplings 86, which are connected to oppositeends of support member 38. Y-piece 82 can be rigid or non-rigid, andconduits 84 are preferably flexible and lightweight. In the illustratedembodiment, the ends of conduits 84 are press-fit onto coupling portions88 of elbow couplings 86. This enables the conduits to be detached, ifnecessary, from the patient interface device.

Elbow couplings 86, are preferably rotateably attached to support member38 so that each elbow coupling is free to rotate independently on arespective end of the support member, as indicated, for example, byarrow D in FIG. 1. The present invention contemplates that any suitableattachment technique can be used to rotateably attach the elbowcouplings to the support member. In the illustrated embodiment, forexample, a collar 90 is provided on the end of support member 38 and theelbow coupling includes an attachment portion 92 that rotateably locksonto collar 90.

FIGS. 5-12 illustrate a second embodiment of a patient interface device100 according to the principles of the present invention. Patientinterface device 100 is similar in many respects to patient interfacedevice 30 discussed above. A key difference resides in type of sealingassembly 102 used to communicate a flow of gas from support member 104to the patient's airway. In the present embodiment, sealing assembly 102is a nasal-cannula type of patient interface, including a pair of prongs106 extending from a base portion 108. Openings 110 are provided inprongs 106 to communicate the interior chamber of each prong with apatient's nostril.

It should be noted that the present invention contemplates that thesealing assembly can include other types, styles, sizes, and shapes ofpatient interface devices in place of the nasal cushion or nasal prongsillustrated and described above. For example, the present inventioncontemplates providing a sealing assembly that communicates with thenasal passages and the mouth, which is typically referred to as afull-face interface.

It should also be noted that while the sealing assembly is shown aboveseparately attached to the remaining portions of the patient interfacedevice, the present invention contemplates a more permanent couplingbetween these elements. For example, the sealing assembly can bephysically bonded to or integrally formed with the support member. Thiscan be done in any conventional manner. Physically bonding the sealingassembly to the support member can be accomplished by means of anon-detachable mechanical coupling or an adhesive. Integrally formingthe sealing assembly with the support member can be accomplished byforming both items from a common material or by two-shot molding thiscombination of elements. Taking this concept one step further, thepresent invention contemplates that the entire patient interface deviceor a subset of the components defining the patient interface device,such as the frame, the support member, and the sealing assembly can beformed as a one-piece structure.

As perhaps best shown in FIGS. 8 and 9, sealing assembly 102 attaches tosupport member 104 by being fit into a cutout 112 defined in a wall ofthe support member. Sealing assembly 102 is configured such that atleast base portion 108 is sufficiently flexible that it can be bent, asleast slightly, and inserted into cutout 112. The base portion ispreferably sized relative to the support member such that the baseportion remains engaged within the cutout due to friction between thebase portion and the walls of support member 104. An alternativeembodiment of the present invention contemplates that base member 108 isrelatively rigid, and support member 104 flexes at least slightly, butto a degree sufficient to allow the base member to fit within cutout112. Yet another embodiment of the present invention contemplates thatprongs 106 are removably attached to base member 108. In which case, thebase member fits into the support member by removing the prongs from thebase member and by removing at least one elbow coupling from the supportmember. The base member is then slid coaxially into the support memberand the prongs and elbow coupling reattached.

As noted above, the present invention contemplates that the elbowcouplings are rotateable relative to the support member. The presentinvention further contemplates that the relative position between theelbow coupling and the support member can be controlled such that theelbow coupling can be located in discrete positions relative to thesupport member. In one embodiment shown in FIG. 6, a ratchet-type ofposition control system is used to maintain elbow coupling 86 b in adiscrete position relative to support member 104. In this embodiment, atleast one tooth 114 is provided on elbow coupling 86 b and a pluralityof tooth engaging members 116 are provided on support member 104. Tooth114 is moveable between tooth engaging members 116 to select therotational angle between the elbow coupling and the support member. Thetooth and tooth engaging members are sized such that the rotationalangle between the elbow coupling and the support member is not easilychanged. It should also be understood that the location of the tooth andthe tooth engaging members can be reversed from that shown, so that thetooth is provided on the support member and the tooth engaging member isprovided on the elbow coupling.

As also noted above, the present invention contemplates that the supportmember is rotateable relative to the frame. The present inventionfurther contemplates that the relative position between the supportmember and the frame can be controlled such that the support member canbe located in discrete positions relative to the frame. In oneembodiment shown in FIGS. 9 and 10, a ratchet-type of position controlsystem is used to maintain support member 104 in a discrete positionrelative to frame 36. In this embodiment, at least one tooth 118, andpreferably a plurality of teeth, are provided on frame 36, and aplurality of engaging members 120 are provided on support member 104.Teeth 118 are moveable along engaging members 120 to select therotational angle between the frame and the support member. The teeth andtooth engaging members are sized such that the rotational angle betweenthe frame and the support member is not easily changed. It should alsobe understood that the location of the teeth and the engaging memberscan be reversed from that shown, so that the teeth are provided on thesupport member and the engaging member is provided on the frame.

Prongs 106 in patient interface device 100 shown in FIGS. 5-10 arebulbous and shaped to fit comfortably in sealing contact with the areaof the nose surrounding each of the patient's nares. Prongs 106 can beformed from any material or combination of materials that is bothflexible—to provide a good seal on the patient, and soft—to provide acomfortable patient contacting surface. Examples of materials suitablefor use as prongs 106, include, but are not limited to: silicone,rubber, foam, or gel.

It is to be further understood that the prongs can have otherconfigurations. FIGS. 11 and 12, for example, illustrate furtherembodiments for the prongs suitable for use with the patient interfacedevice of the present invention. Prong 122 in FIG. 11 includes a baseportion 124 that attaches to the support member and an inflatablebladder 126 having an internal chamber 128. A channel 130 definedthrough the base member and the bladder provides a gas flow pathconnecting the hollow interior of the support member to the patient'sairway. The present invention contemplates that bladder 126 is hollowand permitted to fill with air through a gas flow path 131 when pressureis provided to the patient interface device. This allows the bladder toinflate when the system is pressurized. The present invention alsocontemplates providing a porous material, such as foam or otherparticulate matter, within the bladder to give it some degree ofstructural integrity on its own, rather than relying solely on theinflation of the bladder by the pressure of the gas flow to give thebladder a desired shape.

Prong 132 in FIG. 12, shown partially in cross-section, is defined by aresilient material, such as silicone, and includes a base portion 134 ata proximal end that attaches to the support member. An opening 136 isprovided in a distal end of the prong to communicate the hollow interiorof the support member with the patient's airway. The wall of the prongbetween the proximal and distal end portion includes a bend or gusset138 to allow the distal end of the prong to move or flex in threedimensions. This bending ability allows the distal end of the prong tobe self-positioning on the patient when the patient puts on the patientinterface device an inserts the prongs into his or her nostrils.

FIGS. 13-24 illustrate various alternative embodiments for headgearattachment assemblies suitable for use with the patient interface deviceof the present invention. As such, each of the embodiments shown inthese figures includes a portion, defined by one or more components,that is a component of the patient contacting member and a portion thatcorresponds to the headgear clip.

Referring now to FIGS. 13 and 14, there is shown a first embodiment of aheadgear attachment assembly 138 (shown unassembled) suitable for usewith the patient interface device of the present invention. Headgearattachment assembly 138 includes a headgear clip 140 that inserts into aslot 142 defined in a pad support 144. Headgear clip 140 is held withinslot 142 by a biased cantilever member 146 that is attached to an insert148, which is coupled to pad support 144. More specifically, cantilevermember 146 is biased so as to flex into an opening 150 defined in clip140. As a result, the edge of the cantilever member engages an edge ofthe opening. The circular shape of biased cantilever member 146 andopening 150, and the relative size of the headgear clip and slot 142,allow the headgear clip to swivel or rotate within the slot while theclip is engaged with the pad support.

To release the clip from the pad support, cantilever member 146 must bedeflected away from the headgear clip so that the clip disengages fromthe cantilever member and is free to slide out of slot 142. An opening152 is provided in an exposed surface of pad support 144 to allow accessto cantilever member 146 to apply a deflecting force on the arm againstthe bias force. A slot 154 is provided on clip 140 to attach theheadgear to the clip. It is to be understood that a main feature of thisembodiment is to provide a biased cantilever member associated with thepad support. Although a separate insert 148 that attaches to the padsupport is used to provide this feature in this embodiment, the biasedcantilever member can be formed in other ways, with or without being aseparate component.

FIGS. 15 and 16 illustrate a second embodiment of a headgear attachmentassembly 156 (shown unassembled) suitable for use with the patientinterface device of the present invention. As in the previousembodiment, headgear attachment assembly 156 includes a headgear clip158 that inserts into a slot 160 defined in a pad support 162 and isheld in the slot by a biased cantilever member 164 attached to an insert166 that engages an opening 168 defined in the clip. A unique feature ofthis design is that a slot 170 is added to headgear clip 158 and a key172 is added to biased cantilever member 164 so that a “slot-and-key”configuration is formed, with slot 170 inserting into key 172. Unlikethe prior embodiment, this design prevents movement of the headgear clipin the pad support. It can thus be appreciated that if rotationalmovement is desired, insert 148 is coupled to pad support 162, and if norotation is desired, insert 166 is used.

FIGS. 17 and 18 show a third embodiment of a headgear attachmentassembly 174 (shown unassembled) suitable for use with the patientinterface device of the present invention. Headgear attachment assembly174 includes a headgear clip 176 that inserts into a slot 178 defined ina pad support 180. Headgear clip 176 includes a tab 182 that insertsinto a slot 184 provided in pad support 180. A cover member 186 on padsupport 180 deflects slightly to allow the clip to insert and engagewithin the slot in the pad support. Cover member 186 holds the headgearclip such that tab 182 remains engaged in slot 184. To detach theheadgear clip from the pad support, a slight deflecting force is appliedto cover member 186, for example, by pulling away from the patient onthe exposed end of the headgear clip. The force deflects the covermember outward, widening slot 184, so that tab 182 can disengage fromthe slot.

FIGS. 19-21 illustrate a fourth embodiment of a headgear attachmentassembly 188 suitable for use with the patient interface device of thepresent invention. In this embodiment, a hook 190 is provided onheadgear clip 192. Hook 190 grapples a pin 194 on pad support 196.Attaching hook 190 to pin 194 in this exemplary embodiment involvespositioning headgear clip 192 at an generally 90° angle relative to padsupport 196 and inserting the hook into a slot 198 defined in the padsupport, as indicated by arrow E in FIG. 20. Once inserted, headgearclip 192 is rotated, as indicated by arrow F in FIG. 21, back intoalignment with the pad support, thereby attaching the hook onto the pin.

A fifth embodiment of a headgear attachment assembly 200 suitable foruse with the patient interface device of the present invention is shownin FIGS. 22-24. Headgear attachment assembly 200 includes a headgearclip 202 that inserts into a slot 204 defined in a headgear clip 206.Headgear clip 202 is held within slot 204 by a biased cantilever member208 coupled to pad support 206. FIG. 22 shows a cover member 210 coupledto pad support 206 such that slot 214 is defined between the covermember and the main body of the pad support. FIGS. 23 and 24 show thepad support with the cover member removed, revealing biased cantilevermember 208.

A pair of protrusions 212 a and 212 b are provided on cantilever member208, and a corresponding pair of slots 214 a and 214 b are provided onheadgear clip 202. A central protrusion 216 is also provided oncantilever member 208, and a similarly shaped cutout 218 is defined inheadgear clip 202 so that the headgear clip nests against the centralprotrusion. Preferably a cap 220 is provided over protrusion 216.

Headgear clip 202 attaches to pad support 206 by inserting the headgearclip into slot 214 as shown in FIGS. 22-24. During insertion, cantilevermember 208 deflects away from the headgear clip as the end of theheadgear clip begins to engage protrusion 212 a and 212 b. When fullyinserted, the bias force on cantilever member 208 urges protrusion 212 aand 212 b into slots 214 a and 214 b, as shown in FIG. 24. Theengagement of the protrusions within the slots maintains the headgearclip locked onto the pad support.

To release the headgear clip from the pad support, the user manuallymoves protrusion 212 a and 212 b out of engagement with slots 214 a and214 b by pressing on cap 220. The force on cap 220, and, consequently onprotrusion 216 and the distal end of the cantilever member, causes thecantilever member to deflect away from the headgear clip, releasing theclip from the pad support.

A third embodiment of a patient interface device 222 according to theprinciples of the present invention is shown in FIGS. 25A and 25B.Patient interface device 222 is generally similar to that shown in FIGS.1-10 except for the configuration for the pad support and headgearattachment. It should be noted that while FIGS. 25A and 25B show a nasalcannula type of sealing assembly 40, any conventional sealing assemblycan be used with this patient interface device, including thosediscussed above.

In this embodiment, a patient contacting member 224 is attached to frame226 at an attachment point 228. It should be noted that patientcontacting member 224 can have a variety of configurations, and asimilar shaped contacting member is provided on the other side of theframe. An end of a headgear strap 230 is also attached to the frame atattachment point 228. Preferably, the patient contacting member and theheadgear are rotateably attached to the frame so that both rotate orswivel with respect to the frame. In the illustrated embodiment, a slotis provided in the pad support portion of the patient contacting member,and the headgear strap is inserted into this slot so that the patientcontacting member and the headgear strap are aligned with one another.The present invention also contemplates allowing the headgear strap andthe patient contacting member to move independently, for example, byeliminating the slot in the pad support or by avoiding passing theheadgear strap through such a slot.

FIGS. 26A and 26B illustrate a fourth embodiment of a patient interfacedevice 232 according to the principles of the present invention. Patientinterface device 232 is generally similar to that shown in FIGS. 1-10and 25A-25B, except for the configuration for the pad support and theattachment of the sealing assembly to the frame. It should be noted thatwhile FIGS. 26A and 26B show a nasal cannula type of sealing assembly40, any conventional sealing assembly can be used with this patientinterface device, including those discussed above.

Patient interface device 232 includes patient contacting members 234that are attached to frame 236. In this embodiment, the patientcontacting members are the pads themselves, i.e., the pad supportspresent in the previous embodiments have been eliminated in favor ofconnecting the pads directly to the frame. The pads are either fixed inposition on the frame or rotateably attached thereto. A headgear 238,including headgear straps 240, is attached to the patient interfacedevice in either a fixed or rotateable fashion. In the illustratedembodiment, headgear straps 240 are connected to patient contactingmembers 234 via a loop 242. Alternatively, the present inventioncontemplates not attaching the headgear straps to the patient contactingmembers, so that each is independent of the other. Headgear 238 includesan upper strap 244 and a lower strap 246 generally located at the backof the patient's head. This configuration maximizes the stability of theheadgear.

Unlike the previous embodiment, in this embodiment there is no supportmember to which the sealing assembly is attached. Instead, a sealingassembly 248 is attached directly to one side of frame 236. Sealingassembly 248 corresponds to sealing assembly 40, except that sealingassembly 248 is attached to the frame, not support member 38 or 104.Conduits 250 are coupled to the other side of the frame such that theflow of gas provided by these conduits is delivered to the interior ofsealing assembly 248. In the illustrated exemplary embodiment, an elbowcoupling 252 is provided at the end of each conduit 250 to rotateablyconnect each conduit to the frame. It is to be understood that theconnection of conduit 250 to frame 236 can be done without the elbowcoupling, and can be a fixed connection rather than being rotateable. Inaddition, the rotational angle between the conduit and the frame can becontrolled so that the conduit can be placed in discrete angularpositions relative to the frame. See, e.g., FIG. 6 and the associatedtext describing this figure.

Reference will now be made to FIGS. 27A-30, which show a fifthembodiment of a patient interface device 260 according to the principlesof the present invention shown on a patient. Patient interface device260 includes a support member 262 that supports a sealing assembly 264,which, in the illustrated embodiment, is a pair of nasal prongs 266.Unlike the previous embodiments, patient interface device 260 does notinclude a frame to which the support member is attached. Instead,support member 262 spans the user's face generally below the eyes and issupported directly on the face by patient contacting members 268.Support member 262 is preferably formed from a semi-rigid material suchthat it is sufficiently strong to support the sealing assembly 264, yetflexible enough to fit a variety of differently sized patients. Anexample of a suitable material is silicone that is either thick enoughto provide the necessary support or reinforced.

Support member 262 includes a conduit coupling portion 270 to which apatient circuit 34 is attached. Preferably, a coupling assembly 272 isprovided at conduit coupling portion 270 to couple the patient circuitto the support member in a rotateable fashion. In the illustratedembodiment, coupling assembly 272 is a U-shaped conduit having an upperportion and a lower portion. The present invention contemplatesproviding a swivel joint 274 in coupling assembly 272 so that the upperportion of coupling assembly 272 rotates relative to the lower portion.It is to be understood that other rotateable couplings can be providedto connect the patient circuit to the support member. For example, thepresent invention contemplates coupling an end of a patient circuit to alower portion of coupling assembly 272 in a rotateable fashion.

Support member 262 includes a sealing assembly coupling portion 276 towhich sealing assembly 264 is attached. Support member 262 includes ahollow interior that communicates conduit coupling portion 270 withsealing assembly coupling portion 276. In the illustrated embodiment,sealing assembly coupling portion 276 includes a pair of openings 278defined in a wall of the support member to which prongs 266 areattached. Nasal prongs 266 include a mounting portion 280, which in theillustrated embodiment is a flange that inserts into opening 278. Theedge of opening 278 is seated in a groove 282 next to the flange. Apatient contacting flange 284 is provided at an opposite end of prongs266 to rest against the patient's nose around the nares. A gas flow pathis defined through each prong to communicate the patient's airway withthe interior of support member 262.

The present invention contemplates that sealing assembly couplingportion 276 can be configured to couple any one of a variety ofdifferent types of sealing assemblies to the support member. Forexample, the nasal cushion type of interface shown in FIG. 1 can beprovided on support member 262. It to be understood that the nasalcannula type of patient interface can have other configurations, sizes,and styles as discussed above.

As noted above, patient contacting members 268 are coupled to oppositeends of support member 262. Patient contacting members 268 include a padsupport 286 that is coupled to the support member. Pad support 286 isrigid or semi-rigid and is preferably shaped to provide a comfortablecontact with the patient's face, for example, by having a concavepatient contacting surface. A pad 288 is coupled to pad support 286 inany conventional manner. In the illustrated embodiment, pad 288 isshaped like a sleeve to fit over pad support 286. This configuration forthe patient contacting member allows easy replacement and cleaning ofthe pad.

A pair of headgear attachment assemblies 290 and 292 are provided oneach end of the support member. In the illustrated embodiment, headgearattachment assembly 290 is coupled to coupling assembly 272, andheadgear attachment assembly 292 is provided at an end 294 of supportmember 262. Because support member 262 is a generally tubular structurein the illustrated embodiment, headgear attachment assembly 292 alsoserves to seal end 294 of support member 262 and provides an exhaustassembly 296. In the illustrated embodiment, exhaust assembly 296 is asingle port that is continuously open to allow a continuous flow of gasto the ambient atmosphere. It is to be understood that exhaust assembly296 can have any configuration, including those described above. Eachheadgear attachment assembly 290 and 292 includes a slot 298 and 300,respectively, to which a headgear strap 302 is connected.

By providing conduit coupling 270 at one end of support member 262, andexhaust assembly 296 at the other, a continuous flow of gas ismaintained from the one side of the structure to the other. By havingthis continuous flow directed past the nasal prongs, rebreathing ofexhaled CO₂ by the patient is drastically reducing, if not eliminated.

Patient contacting members 268 are coupled to headgear attachmentassembly 292 and to coupling assembly 272. Preferably, patientcontacting members 268 are rotateably coupled to headgear attachmentassembly 292 and to coupling assembly 272. A first mounting member 304is provided on headgear attachment assembly 292 and coupling assembly272. A second mounting member 306 is provided on pad support 286. Firstmounting member 304 is preferably rotateably coupled to second mountingmember 306 such that the patient contacting members rotate or swivelwith respect to support member 262.

FIGS. 31A-31C illustrate a sixth embodiment of a patient interfacedevice 308 according to the principles of the present invention shown ona patient. Patient interface device 308 is generally similar to thatshown in FIGS. 27A-30 except that patient contacting members 310 arecoupled directly to a support member 312 in a fixed position, i.e., thepatient contacting members do not rotate relative to the support member.A pair of headgear straps 314 and 316 are coupled to patient contactingmembers 310.

A sealing assembly support 318 is coupled to support member 312 andsupports a sealing assembly, which is either a nasal cannula typeinterface (as shown) or a sealing cushion. Sealing assembly support 318is preferably rotateably coupled to support member 312 so that thepatient can control the position of the sealing assembly relative to thesupport member. An elbow coupling 320 is provided at an end portion ofsupport member 312 to couple patient circuit 34 to the support member.Preferably a joint 322 between the elbow coupling and the support memberand a joint 324 between the patient circuit and the elbow coupling areswivel joints to allow rotational movement between the two members beingjoined.

A seventh embodiment of a patient interface device 326 according to theprinciples of the present invention is shown in FIGS. 32A and 32B. Thepatient interface device in this embodiment is similar to that discussedabove with respect to FIGS. 27A-31C except that in the presentembodiment, patient interface device 326 does not include the patientcontacting members. Instead, support member 328 includes patientcontacting portions 330 that rest on the surface of the patient.

Support member 328 is generally U-shaped and the end of each leg of the“U” rests on the patient. Of course, padding is provided on the end ofeach leg for optimum patient comfort. In addition, patient contactingportions 330 have a patient contacting surface that is contoured tocorrespond to the features of a human face. Headgear straps 331 are alsoconnected near the end of each leg of the U-shaped support member.

Support member 328 includes a sealing assembly coupling portion 332 towhich a sealing assembly is attached. The sealing assembly that can becoupled to the support member is any of the sealing assemblies discussedherein, such as the nasal cannula or nasal pong types of seals. Althoughnot shown in the illustrated embodiment, a patient circuit connects tosupport member 328 at any location on the support member, and a gas flowpath is defined in the support member from the point where the patientcircuit is connected to sealing assembly coupling portion 332. This gasflow path communicates the flow of gas provided by the pressure supportsystem with an airway of a patient.

FIGS. 33A and 33B illustrate an eight embodiment of a patient interfacedevice 334 according to the principles of the present invention. Patientinterface device 334 is generally similar to that shown in FIGS. 32A and32B except that a support member 336 includes a pair of relatively largecheek contacting portions 338 to maximize the disbursement of thestrapping forces on the patient's face. The large cheek contactingportions also enhance the stability of the support member on thepatient. Support member 336 includes a sealing assembly coupling portion340 to which a sealing assembly is attached. The sealing assembly thatcan be coupled to the support member is any of the sealing assembliesdiscussed herein, such as the nasal cannula or nasal pong types ofseals. A pad 342 is provided on the patient contacting side of the cheekcontacting portions of the support member. In addition, cheek contactingportions 338 are contoured to correspond to the features of a humanface. A rotateable coupling 344 is provided on each end of supportmember 336 so that conduits 84 are rotateably coupled to the supportmember.

FIGS. 34A and 34B illustrate a ninth embodiment of a patient interfacedevice 346 according to the principles of the present invention. Patientinterface device 346 is generally similar to that shown in FIGS. 33A and33B except that conduits 84 are coupled to a support member 348 at alocation that is closer to a sealing assembly support portion 350 thanin the earlier embodiment. Support member 348 still includes cheekcontacting portions 352. However, the cheek contacting portions areprovided at a posterior location relative to conduit couplings 354.Preferably, conduit coupling 354 rotateably couples conduits 84 to ahollow portion of support member 348 to communicate a flow of gas to asealing assembly 356 mounted on sealing assembly support portion 350 ofsupport member 348. This embodiment for patient interface device 346reduces the amount of material provided on the face of the patient.

It should be noted that pads 358 are provided on the patient contactingsides of the cheek support portions of the support member. In addition,cheek contacting portions 352 have a patient contacting surface that iscontoured to correspond to the features of a human face. Sealingassembly 356 is preferably rotateably coupled to support member 348 sothat the patient can control the position of the sealing assemblyrelative to the support member. While nasal-cannula type of sealingassembly is shown, it is to be understood that any sealing assembly canbe supported by the support member.

FIGS. 35A and 35B illustrate a tenth embodiment of a patient interfacedevice 360 according to the principles of the present invention. Patientinterface 360 is similar to that of FIGS. 27A-34, except that in thisembodiment, patient circuit 34 is coupled to a central portion 364 of asupport member 362 via a coupling 366. Coupling 366 is preferably aswivel coupling so that patient circuit 34 is rotateable relative tosupport member 362. Central portion 364 of support member 362 alsoserves as the sealing assembly, for example, by including prongs thatextend from the patient side of the support member or by providing anopening on the patient contacting side of the support member. Of course,the support member should be formed from a material suitable to functionas the sealing assembly. It is to be understood that a separate sealingassembly can be coupled to the support member, as in the previousembodiments instead of having the support member function as its ownsealing assembly.

A headgear assembly 368 having a pair of headgear straps 370 is coupledto support member 362. A pad 372 is provided between the patient and thelocation where the headgear strap and the support member are joined. Anose piece 374 is also coupled to support member 362. In an exemplaryembodiment of the present invention, nose piece 374 is a nasal dilatingdevice that adheres to the lateral surfaces of each nostril and isbiased so as to distend the nostrils outward. It is generally understoodthat deflecting the surface of the nostril outward, opens or widens thenasal passages to reduce the resistance of the flow of gas through thenasal passages.

Finally, a collar 376 connects the patient to patient circuit 34 via acoupling member 378. Attaching the patient circuit to the patient inthis manner helps manage the patient circuit to keep it under controlwhile the pressure support system is being used. Although collar 376 isshown attached to the patient's neck, it is to be understood that thecollar can be attached to other locations of the patient, such as theshoulder, thorax, arm, and/or waist.

FIGS. 36A-36C illustrate an eleventh embodiment of a patient interfacedevice 380 according to the principles of the present invention. Patientinterface device 380 includes a support member 382 that is coupled to asealing assembly support 384. A unique feature of support member 382 isthat it extends from under the patient's nose, across the cheeks, up thesides of the head, and over the top of the patient's head, where itjoins with patient circuit 34. Preferably, support member 382 is formedfrom a crush resistant tubing, so that the patient can lie on his or herside while using the pressure support system coupled to patientinterface device 380 without impairing the flow of gas to the patient.

In an exemplary embodiment of the present invention, sealing assemblysupport 384 itself serves as the sealing assembly, for example, byincluding prongs or a patient contacting cushion integral with thesealing assembly support. Alternatively, a separate sealing assemblyhaving any of the configurations discussed above can be attached to thesealing assembly support. Sealing assembly support 384 is eitherintegral with support member 328 or is coupled thereto, so that thesealing assembly or the sealing assembly support member can beselectively attached to the support member. If the sealing assemblysupport is not integral with the support member, it is preferable thatthe sealing assembly support is rotateable relative to the supportmember.

A patient contacting member 386 is coupled to support member 382.Patient contacting member 386 is a single or multiple-piece assemblythat includes a headgear attachment portion and a patient contactingportion. The patient contacting portion of patient contacting member 386is preferably contoured to correspond to the facial features of thepatient, and is preferably easily removable from the support member sothat the patient contacting portion can be easily replaced. In theillustrated embodiment, a loop 388 connects patient contacting member386 to support member 382. A pair of headgear straps 390 and 392 areconnected to patient contacting member 386 to assist in securing patientinterface device 380 to the face of the patient.

FIGS. 37 and 38 illustrate a twelfth embodiment of a patient interfacedevice 394 according to the principles of the present invention. Patientinterface device 394 includes the features of the present inventiondiscussed above, in addition to a sealing assembly extending portion396. Sealing assembly extending portion 396 moves a sealing assembly 398in a direction, as indicated by arrow G, toward and away from a sealingassembly support portion 400 of a support member 402.

In an illustrated exemplary embodiment of the present invention, sealingassembly extending portion 396 is formed from a corrugated segment 404that can be extended or retracted as desired to position sealingassembly 398 at the airway of the patient. Preferably, corrugatedsegment 404 permits movement of sealing assembly 398 to the desiredposition, yet is resistant to inadvertent movement so the sealingassembly is not easily dislodged from the airway of the patient.

FIG. 39 illustrates a thirteenth embodiment of a patient interfacedevice 406 according to the principles of the present invention. Patientinterface device 406 is similar to the patient interface devicesdiscussed above, except that a nose contacting portion 408 is providedto facilitate attachment of a support member 410 to a face of a patient.Nose contacting portion 408 extends from support member 410 over the tipof the nose and contacts the nose above the tip. The present inventioncontemplates that nose contacting portion 408 can be adhered to the noseor simply rest on the nose without being adhered thereto. Thisembodiment also illustrates an exhaust assembly 412 in the form of aplurality of vent ports provided at the central portion of supportmember 410.

FIG. 40 is a perspective view of a further embodiment for a sealingassembly 414 suitable for use with the patient interface devices of thepresent invention. Sealing assembly 414 includes a base portion 416 anda pair of prongs 418 coupled thereto. The base portion couples with thesupport member in any of the embodiments for the patient interfacedevice discussed herein. Each prong includes a passage 420 thatcommunicates an airway of a patient with an interior of the baseportion.

A unique feature of sealing assembly 414 is that it includes a sealingmaterial 422 disposed around each prong. In an exemplary embodiment ofthe present invention, sealing material 422 is a conformable substancethat the user shapes or molds to provide a customized seal for eachprong. Once molded to the desired shape, sealing material 422 preferablyretains that shape. Therefore, this embodiment of the present inventioncontemplates that sealing material 422 must be activated, for example byheating, in order for the shape of that material to be changed.

In another embodiment, which can be used alone or in combination withthe customizable feature of the first embodiment, sealing material 422includes an adhesive property to assist in maintaining a good seal withthe patient when the patient interface device is worn by the patient.Thus, sealing material 422 can be a somewhat sticky puddy that ismoldable to the features of the user and provides a good seal with theuser's skin.

A fourteenth embodiment of a patient interface device 424 according tothe principles of the present invention is shown in FIGS. 41 and 42.Patient interface device 424 includes a support member 426 that iscoupled to a flow of gas (not shown) using any coupling technique. A gasflow path is defined in the support member from the point where thepatient circuit is coupled to the support member to a sealing assemblysupport 428 on which are located a pair of nasal prongs 430. Openings432 are defined in the sealing assembly support to communicate a flow ofgas to an interior of each prong.

In an exemplary embodiment of the present invention, sealing assemblysupport 428 is rotateably coupled to support member 426 so that therotational angle of the nasal prongs relative to the support member canbe changed, as indicated by two-headed arrow H. The coupling of thesupport member with the sealing assembly support can be a ratchet-typeof coupling that allows the sealing assembly support to be located indiscrete positions relative to the support member. Alternatively, thecoupling between the support member and the sealing assembly support canprovide a continuous range of adjustability.

Nasal prongs 430 are coupled to support member 426 such that the nasalprongs can slide, either independently or together, along a longitudinalaxis of the support member, as indicated by two-headed arrow I in FIG.41. The sliding displacement of one of the prongs is shown in FIG. 42.Nasal prongs 430 can be coupled to support member 426 in a variety ofways that provide this sliding capability. An example of one suchtechnique for slideably securing the nasal prongs to the support memberis shown in FIGS. 41 and 42. In this illustrated embodiment, each prongis attached to or integral with a coupling sleeve 434. The couplingsleeve is provided around the support member such that the sleeve slidesalong the length of the support member while still providing a good sealwith the support member, so that gas provided through opening 432 doesnot leak around the sleeve. It can be appreciated that the nasal prongscan move along the length of the support member in the same direction orin opposite directions to alter the distance between the prongs. Theamount of movement along the support member is not limited, so long asan interior of the prongs remains in fluid communication with opening432 so that the flow of gas is communicated to the prong.

FIG. 43 illustrates a fifteenth embodiment of a patient interface device436 according to the principles of the present invention. Patientinterface device 436 includes a support member 438 that supports asealing assembly 440. Support member 438 is either hollow or partiallyhollow to communicate a flow of gas from a patient circuit (not shown)to the sealing assembly or the flow of gas is coupled directly to thesupport assembly. A patient contacting member 442 is coupled to thesupport member. In this embodiment, the position of the patientcontacting member along the length of the support member is adjustable,as indicated by arrow J, by means of an adjustment assembly, generallyindicated at 444, that connects the patient contacting member and thesupport member.

In the illustrated exemplary embodiment, adjustment assembly 444includes a track 446 with a plurality of notches 448 disposed on supportmember 438. Patient contacting member 442 includes a pin 450 disposed intrack 446. When pin 450 is located in one of the notches, patientcontacting member 442 can rotate or swivel about the pin, as indicatedby arrow K. Pin 450 can be moved along the length of the support memberto other notches, thereby changing the position of the patientcontacting member on the support member. The notches provide discretelocations in which the pin can be located and held. A headgear strap 452is connected to support member 438, as shown, or is connected to thepatient contacting member in any fashion, including the headgearattachment techniques discussed above.

FIGS. 44-45 illustrate a sixteenth embodiment of a patient interfacedevice 454 according to the principles of the present invention. Patientinterface device 454 includes a support member 456 that spans the faceof the user. An inflatable bladder 458 is coupled to the patient side ofthe support member. In the illustrated exemplary embedment, inflatablebladder is sized and shaped so as to generally match a major portion ofthe support member. The bladder can be filed at all times or can befilled by the flow of gas delivered through the patient circuit (notshown). In the latter configuration, a sealing assembly 460 is coupleddirectly to the bladder such that gas from the bladder passes to theairway of the patient through the sealing assembly. In the illustratedembodiment, sealing assembly 460 is a pair of nasal prongs. It is to beunderstood that other types of sealing assemblies, such as a cushion,can be used.

Bladder 458 can rest directly on the surface of the patient or a paddingcan be provided between the bladder and the patient. A headgear strap462 is connected to support member 456 in any fashion, including theheadgear attachment techniques discussed above.

FIGS. 46-49 illustrate an alternative configuration or technique forattaching a sealing assembly 502 to a support member 504 in a patientinterface device 500. In this embodiment, a snap assembly, generallyindicated at 506, is provided to selective couple the sealing assemblyto the support member. More specifically, the snap assembly includes atleast one tab 508 associated with the sealing assembly and correspondinggrooves 510 associated with the support member. In the illustratedembodiment, three tabs and grooves are provided on the sealing assemblyand support member.

It is to be understood that the number of tabs and groove, theirlocation, and their configuration can be altered while remaining withinthe spirit of the present invention. For example, the present inventioncontemplates providing the tabs on support member 504 and the grooves onthe sealing assembly 502. It should also be understood that the sealingassembly and the support member can also have configurations other thanthose illustrated in FIGS. 46-49. For example, the sealing assembly caninclude nasal prongs as described above.

In the illustrated exemplary embodiment, tabs 508 are defined by asupport frame 512 that forms part of the sealing assembly. Morespecifically, the sealing assembly is defined by a patient contactingmember 511, such as the cushion or nasal prongs, and the support frame.In an exemplary embodiment, support frame 512 is formed from arelatively rigid material so that it provides strong and secure pointsof attachment for the sealing assembly to the support member. In anexemplary embodiment, support frame 512 is formed from a rigid plasticor metal. Of course, the present invention also contemplates forming thesupport frame or portions thereof from other materials, includingsemi-rigid or flexible materials.

The support frame and the patient contacting member can be coupled toone another in any conventional manner. However, in an exemplaryembodiment, the patient contacting member is molded over the supportframe. To ensure a secure attachment of the patient contacting member tothe support frame, a plurality of openings 514 are formed in the supportframe so that the material defining the patient contacting member canflow into these openings. The patient contacting member is molded to thesupport frame such that tabs 508 protrude from the surface of thepatient contacting member to engage the grooves in the support member.

As perhaps best shown in FIGS. 46 and 49, sealing assembly 502 includesa first opening 516 that corresponds or mates with a correspondingopening 518 in support member 504. Sealing assembly 502 also includes asecond opening 520 to communicate an interior of the seal with an airwayof the patient.

By allowing the sealing assembly to snap onto the support member in asecure and stable fashion while still allowing the sealing assembly tobe removed from the support member, it becomes very easy to remove thesealing assembly for cleaning purposes and reattach it. This also allowsfor a great degree of flexibility in the size, configuration, shape,material, etc, for the sealing member, in that any such sealing membercan be used in conjunction with the support member. The support framealso serves to provide a stable and secure attachment of the sealingmember to the support member.

Although the invention has been described in detail for the purpose ofillustration based on what is currently considered to be the mostpractical and preferred embodiments, it is to be understood that suchdetail is solely for that purpose and that the invention is not limitedto the disclosed embodiments, but, on the contrary, is intended to covermodifications and equivalent arrangements that are within the spirit andscope of the appended claims. For example, it is to be understood thatthe present invention contemplates that, to the extent possible, one ormore features of any embodiment can be combined with one or morefeatures of any other embodiment.

What is claimed is:
 1. A patient interface device comprising: a supportmember sized and configured to span at least a portion of a patient'sface while remaining below the patient's eyes responsive to the patientinterface device being donned by such a patient, the support memberhaving a coupling portion configured to continuously span from a firstside of a patient's face on a first side of the patient's nose to asecond, opposite side of the patient's face on a second, opposite sideof the patient's nose responsive to the patient interface device beingdonned by such a patient; and a sealing assembly operatively coupled tothe support member at the coupling portion in a manner wherein thesealing assembly is rotatable relative to the coupling portion about alongitudinal axis of the coupling portion or slideable relative to thecoupling portion along the longitudinal axis of the coupling portionwhile remaining in fluid communication with an interior of the supportmember, wherein the support member defines a gas carrying conduitadapted to carry a flow of gas to the sealing assembly, wherein thesupport member is a single-piece unitary member and includes a conduitcoupling portion adapted to be coupled to a patient circuit, and whereinthe conduit coupling portion is provided at a first end of the supportmember on a first side of the coupling portion, and wherein an exhaustassembly is provided at a second end of the support member on a secondside of the coupling portion such that a continuous flow of gas ismaintained from the first end of the support member to the second end ofthe support member through the coupling portion.
 2. The interface deviceof claim 1, wherein the sealing assembly includes a pair of nasalprongs, wherein each prong inserts at least partially into a nostril ofsuch a patient.
 3. The interface device of claim 1, wherein the sealingassembly is a cushion that includes a sealing surface adapted tosurround a patient's nares and an opening defined in the cushion adaptedto communicate an interior of the cushion with an airway of such apatient.
 4. The interface device of claim 1, further comprising a pairof patient contacting members adjustably coupled to the support member.5. The interface device of claim 4, wherein the pair of patientcontacting members include a headgear attachment portion.
 6. Theinterface device of claim 5, further comprising a headgear assemblyoperatively coupled to the headgear attachment portion.
 7. The interfacedevice of claim 6, wherein the headgear assembly is rotateably attachedto the headgear attachment portion.
 8. The interface device of claim 1,wherein the support member is adapted to span a patient's face along afirst axis generally parallel to an axis defined through such apatient's eyes.